Inhaled Sodium Pyruvate for the Treatment of Cystic Fibrosis.

NCT00308243 | Completed Phase 1

• 2 other identifiers: CSI-N115-I-010-01Orphan Drug 02-1656
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

It is hypothesized that the inhalation of sodium pyruvate will reduce lung damage in patients with Cystic Fibrosis (CF) by its ability to reduce levels of toxic reactive oxygen and nitrogen compounds associated with the chronic inflammatory component of the disease. The primary objective of the study is to assess the safety of inhaled sodium pyruvate in 0.9% sodium chloride (saline) solution in people with CF. Further, to determine whether inhaled sodium pyruvate will improve lung function, as determined by spirometry, or reduced inflammatory markers in induced sputum of people with CF.

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis; Sodium Pyruvate; Reactive Oxygen Species; Inflammation of Lung

Outcome Measures

Primary Outcomes (1)

• The primary outcome variable is the assessment of safety of inhaled sodium pyruvate in subjects with CF.

Secondary Outcomes (1)

• The secondary outcome variable is the determination of improvement in lungs of CF subjects as determined by measurement of FEV1 and/or as determined by measurement of reduced inflammatory markers in induced sputum.

Interventions

Sodium Pyruvate in 0.9% Sodium Chloride Solution DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of CF using Cystic Fibrosis Foundation criteria.
• FEV1 \>40% predicted
• Colonization with Pseudomonas aeruginosa - (\>= 2 positive cultures over past 12 months)
• \>18 years of age
• Stable respiratory status without dyspnea
• Non-smoker
• Able to perform sputum induction

You may not qualify if:

• Severe CF with an FEV1 of \<40% predicted
• Lung disease not CF related
• Positive culture for Burkholderia cepacia
• Active allergic bronchopulmonary aspergillosis
• Clinically significant cardiac disease
• Pregnancy
• Females of child bearing age not using contraception
• Females lactating
• \<18 years of age
• Systemic steroid treatment within 1 month
• Hospitalization within 3 months due to airway disease
• Immunotherapy
• Changes in respiratory medication use within 1 month
• New medications within 1 month
• Participation in research study within 1 month

Sponsors & Collaborators

• Emphycorp: lead
• Cellular Sciences, inc.: collaborator

Study Sites (1)

University of Minnesota Medical School, The Minnesota Cystic Fibrosis Center

Minneapolis, Minnesota, 55455, United States

Location

Related Links

• Click here for more information about this study: Inhaled Sodium Pyruvate for the Treatment of Cystic Fibrosis. A Phase I, Double Blind, Placebo Controlled, Safety Study. (Stage 1)

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Joanne Billings, MD

  University of Minnesota; Pulmonary, Allergy & Critical Care Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 27, 2006
• First Posted: March 29, 2006
• Study Start: March 1, 2006
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: July 19, 2011

Record last verified: 2011-07

Locations

US (1)